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Combining Imiquimod and Radiation for Mycosis Fungoides

This study is testing a new way to treat Mycosis Fungoides (MF), a type of skin lymphoma. It combines a cream called Imiquimod with local radiation therapy. Researchers want to see how well this combination works to reduce MF lesions and if it's safe. You might be able to join if you are 18-90 years old, have confirmed MF (stages IA-IIB), have tried other treatments that didn't work, and have stable disease with at least four active lesions. The study aims to enroll 25 participants. The current status of the study is unclear.

Study design
This interventional study plans to enroll 25 participants. It is testing a specific treatment combination, but the phase of the study is not specified.
What's involved
Participants will apply Imiquimod cream to their skin for 6 weeks, 5 days a week. One week after finishing the cream, they will receive radiation therapy over two days.
Compensation
Not stated in the trial record.
Follow-up
The study will measure how well the treatment works at 8 weeks and track any side effects for 12 weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05838599

Combining Topical Imiquimod With Local Radiotherapy for Treatment of Mycosis Fungoides

Recruiting
EARLY_PHASE1Ages 18–90InterventionalTreatment
Northwestern University
~25 participants
Updated 2026-05-01 on ClinicalTrials.gov
What's tested:ImiquimodRadiation Therapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8.
Measured over 8 weeks
+1 more outcome measured

Conditions

Mycosis Fungoides

Explore related trials

Mycosis Fungoides

NCT05838599

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Northwestern University Department of Dermatology

    Chicago, Illinoisno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Alan Zhou · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

Dermatology Clinical Trials Unit
[email protected]
312-503-5944
Email the study team

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Eligibility criteria

Inclusion

Patients must have confirmed stage IA-IIB mycosis fungoides.
Patients must be 18-90 years of age.
Patients must have failed at least one standard therapy for MF.
Patients must have active, but stable disease for \>6 months.
Patients must have 4 or more discrete MF lesions with at least 2 of them with minimum combined surface area of \>50cm2.
POCBP must have a negative pregnancy test prior to registration on study.
Patients must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion

Patients who are on current systemic or topical CTCL therapy, unless stable on the treatment for \>6 months.
Patients who have received antibiotic therapy within 4 weeks of study enrollment.
Patients who are pregnant or nursing. Pregnant people are excluded from this study because IMQ is an agent with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the gestational parent with IMQ, breastfeeding should be discontinued if the parent is treated with IMQ.
Patients with psychiatric illness/social situations that would limit compliance with study requirements.

What this trial measures

  • Efficacy of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF as measured by mSWAT at week 8.8 weeks

    The primary efficacy endpoint will be skin disease response as measured by mSWAT (Modified Severity-Weighted Assessment Tool) at week 8.

  • Incidence of treatment-emergent adverse events (safety and tolerability) of a combination local radiotherapy and topical imiquimod approach for the treatment of conventional (CD4+) MF.12 weeks

    Adverse event occurrence during study.